Timeline of Liver Monitoring Requirements

October 1997 – Warner-Lambert issues a warning letter about possible liver damage risks associated with Rezulin use. As of October 31, 1997, Warner-Lambert incorporates liver monitoring requirements in its labeling for the first time. The requirements specify that patients taking Rezulin should have their liver enzymes tested the first one to two months of therapy, and then every three months for the remainder of the first year (five times during the first year), and then periodically thereafter. One person taking Rezulin has been reported to have died from liver failure after taking Rezulin.

December 1997 – It is reported that six people have died worldwide from taking Rezulin, prompting the British government to conclude that “the risks of troglitazone [Rezulin] outweigh the potential benefits.” The drug is then withdrawn in the United Kingdom. Instead of withdrawing Rezulin in the United States, the FDA suggests that Warner-Lambert modify the liver monitoring requirements. A boxed warning is added to Rezulin’s labeling, which specifies that individuals taking Rezulin should have their liver enzymes measured at the start of therapy, every month for the first six months of treatment, and then every other month for the remainder of the first year (10 times during the first year), and then periodically thereafter.

June 1998 – The FDA reveals that 21 people have died from taking Rezulin, prompting Public Citizen to petition the FDA for Rezulin’s removal in the United States.

July 1998 – Public Citizen submits its letter to the FDA petitioning for Rezulin’s removal. On July 27, 1998, Warner-Lambert modifies its labeling requirements for the third time. It is now recommended that patients taking Rezulin have their liver enzymes checked at the start of therapy, monthly for the first eight months of therapy, and then every two months for the remainder of the first year (11 times in the first year), and then periodically thereafter.

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Greetings from Nadia

A few facts about me in case you are new to my column and site.

My life in the diabetes community started at a young age as the secret keeper of my maternal and paternal Grandmothers. They both had type 2 diabetes and my days spent alone with them exposed me to their misunderstanding of how their diabetes really affected them. Eating candy bars, hiding the candy wrappers and smoking cigarettes seemed innocent enough to them. A decade later I married a type 1 person living with diabetes and experienced the full court of the diabetes spectrum with my type 2 family members and type 1 husband of almost 20 years.

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My grandmothers, the type 2 have struggled with their diabetes as long as I could remember. Later my mother followed in her mother’s footsteps. Sadly, my brother followed in my mother’s footsteps and experienced an early passing at the age of 53. My brother Jamal’s passing had the greatest impact on me. Probably because were the Irish twins; eleven months apart and his departure devastated me.

As I tell most people, diabetes is not a glamorous profession. Most people that work in the industry have a personal connection. This is why I am still here publishing after 26 years.

On the flip side of the coin, helping and inspiring people is my mission. I understand the daily challenges you face regardless of your education, IQ and economic circumstance. I am not a healthcare professional. Simply a lay person who has lived with a Type 1 and Type 2 family member who struggled with their disease. My former Type 1 husband was a role model in how to manage your diabetes, while my intelligent family members were role models on how an invisible disease can be misunderstood, devastating the quality of their life while leaving heart broken family members behind.

The perils of my experience have taught me to never judge anyone. As knowledgeable as I am, I also realize that I have no idea of the strings that pull at each person heart.

What I love about the diabetes community?

Once I meet someone and we share that we have a common experience; their diabetes and my life long experience as a care taker, we tend to have an instant bond. Think about it. How many people do you meet who you feel really get you right after your introduction? The conversations that follow tend to be very personal. Not a common experience with all strangers.

AskNadia Column

I started this column because where ever I go, people tend to ask me a lot of diabetes questions.

My answers are my opinions and it is not to be replaced by your healthcare professional’s opinion. The answers to your question in most cases will include research and other links to give you a borader perspective on your question.